Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas

Metastatic Pancreatic Cancer Clinical Trial

Official title:

A Randomized Phase III Study of Weekly ABI-007 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Metastatic Adenocarcinoma of the Pancreas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00844649
• Other study ID #: CA046
• Status: Completed
• Phase: Phase 3
• Start date: March 1, 2009
• Est. completion date: April 9, 2013

Study information

• Verified date: November 2019
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase III Metastatic Pancreatic Cancer

Description:

A Phase III, open-label randomized, multicenter trial to compare ABI-007(Albumin-bound Paclitaxel)in combination with gemcitabine administered weekly to standard treatment (gemcitabine monotherapy) with respect to overall survival, objective tumor response rate and Progression Free Survival (PFS) in patients diagnosed with metastatic adenocarcinoma of the pancreas.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 861
• Est. completion date: April 9, 2013
• Est. primary completion date: September 17, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria

A participant will be eligible for inclusion in this study only if all of the following criteria are met:

1. Participant has definitive histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. The definitive diagnosis of metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data. Participants with islet cell neoplasms are excluded.

2. Initial diagnosis of metastatic disease must have occurred =6 weeks prior to randomization in the study.

3. Patient has one or more metastatic tumors measurable by Computed Tomography (CT) scan or Magnetic resonance imaging (MRI), if patient is allergic to CT contrast media).

4. Male or non-pregnant and non-lactating female, and = 18 years of age. If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test Beta-Human Chorionic Gonadotropin (ß-hCG) documented 72 hours prior to the first administration of study drug.

If sexually active, the patient must agree to use contraception considered adequate and appropriate by the Investigator during the period of administration of study drug. In addition, male and female patients must utilize contraception after the end of treatment as recommended in the product's Summary of Product Characteristics or Prescribing Information provided in the study manual.

5. Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with 5-Fluorouracil (5-FU) or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present. Patients having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for this study.

6. Patient has adequate biological parameters as demonstrated by the following blood counts at Baseline (obtained =14 days prior to randomization):

Absolute neutrophil count (ANC) = 1.5 × 10^9/L; Platelet count = 100,000/mm^3 (100 × 10^9/L); Hemoglobin (Hgb) = 9 g/dL.

7. Patient has the following blood chemistry levels at Baseline (obtained =14 days prior to randomization):

Aspartate Transaminase (AST), Serum Glutamic-Oxaloacetic Transaminase (SGOT), Alanine Transaminase ( ALT) Serum Glutamic-Pyruvic Transaminase (SGPT) = 2.5 × upper limit of normal range (ULN), unless liver metastases are clearly present, then = 5 × ULN is allowed Total bilirubin = ULN Serum creatinine within normal limits or calculated clearance = 60 mL/min/1.73 m^2 for patients with serum creatinine levels above or below the institutional normal value. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (e.g., using the Cockroft-Gault formula). For patients with a Body Mass Index (BMI) >30 kg/m^2, lean body weight should be used instead.

8. Patient has acceptable coagulation studies (obtained =14 days prior to randomization) as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits (± 15%).

9. Patient has no clinically significant abnormalities in urinalysis results (obtained =14 days prior to randomization).

10. Patient has a Karnofsky performance status (KPS) = 70. Two observers will be required to assess KPS. If discrepant, the one with the lowest assessment will be considered true.

11. Patients should be asymptomatic for jaundice prior to Day 1. Significant or symptomatic amounts of ascites should be drained prior to Day 1. Pain symptoms should be stable and should not require modifications in analgesic management prior to Day 1.

12. Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities.

Exclusion Criteria

A patient will not be eligible for inclusion in this study if any of the following criteria apply:

1. Patient has known brain metastases, unless previously treated and well-controlled for at least 3 months (defined as clinically stable, no edema, no steroids and stable in 2 scans at least 4 weeks apart).

2. Patient has only locally advanced disease.

3. Patient has experienced a =10% decrease in KPS between baseline visit and within 72 hours prior to randomization.

4. Patient has a =20% decrease in serum albumin level between baseline visit and within 72 hours prior to randomization.

5. History of malignancy in the last 5 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years.

6. Patient uses Coumadin.

7. Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.

8. Patient has known historical or active infection with Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C.

9. Patient has undergone major surgery, other than diagnostic surgery (i.e.--surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.

10. Patient has a history of allergy or hypersensitivity to any of the study drugs or any of their excipients, or the patient exhibits any of the events outlined in the Contraindications or Special Warnings and Precautions sections of the product or comparator Summary of Product Characteristics (SmPC) or Prescribing Information.

11. History of connective tissue disorders (e.g., lupus, scleroderma, arteritis nodosa).

12. Patients with a history of interstitial lung disease.

13. History of chronic leukemias (e.g., chronic lymphocytic leukemia).

14. Patients with high cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year.

15. History of Peripheral Artery Disease (e.g,. claudication, Leo Buerger's disease).

16. Patient has serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the patient's safety or the study data integrity.

17. Patient is enrolled in any other clinical protocol or investigational trial.

18. Patient is unwilling or unable to comply with study procedures, or is planning to take vacation for 7 or more consecutive days during the course of the study.

Related Conditions & MeSH terms

• Adenocarcinoma
• Metastatic Pancreatic Cancer

Intervention

Drug:
• Albumin-bound paclitaxel (ABI-007)
ABI-007 125 mg/m^2 administered by intravenous infusion
• Gemcitabine
Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks, Day 1 through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks, Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward).

Locations

Country	Name	City	State
Australia	Adelaide Cancer Centre (T/A Ashford Cancer Ctr)	Ashford	South Australia
Australia	Bankstown-Lidcombe Hospital	Bankstown	New South Wales
Australia	Flinders Medical Center	Bedford Park	South Australia
Australia	Medical Oncology Unit, Bendigo Health	Bendigo	Victoria
Australia	Macarthur Cancer Therapy Center	Campbelltown	New South Wales
Australia	Concord Hospital	Concord	New South Wales
Australia	St. Vincent's Hospital	Darlinghurst	New South Wales
Australia	Monash Medical Centre	East Bentleigh	Victoria
Australia	Western Hospital	Footscray	Victoria
Australia	Peninsula Oncology Centre	Frankston	Victoria
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	Royal Hobart Hospital	Hobart	Tasmania
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Haematology Oncology Clinics of Australasia-Gold Coast	Milton	Queensland
Australia	Haemotology & Oncology Australasia (HOCA)	Milton	Queensland
Australia	Sir Charles Gairdner Hospital	Nedlands, Perth	Western Australia
Australia	Calvary North Adelaide Hospital	North Adelaide	South Australia
Australia	Prince of Wales Hospital	Randwick	New South Wales
Australia	Newcastle Hospital	Waratah	New South Wales
Australia	Border Medical Oncology	Wodonga	Victoria
Australia	Southern Medical Day Care Centre	Wollongong	New South Wales
Austria	Krankenhaus der Barmherzigen Schwestern Linz	Linz
Austria	Landesklinikum St. Pölten	St. Pölten
Austria	Medizinische Universität Wien	Vienna
Austria	Klinikum Wels-Grieskirchen GmbH	Wels
Belgium	Imelda VZW , Gastro-Enterology	Bonheiden
Belgium	Hôpital Erasme, Gastro-Enterology	Brussels
Belgium	AZ Groeninge - Campus Sint-Niklaas	Kortrijk
Belgium	H.-Hartziekenhuis Roeselare-Menen vzw	Roeselare
Canada	The Royal Victoria Hospital-Barrie	Barrie	Ontario
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Centre Hospitalier de L'Universite de Montreal St-Luc	Montreal
Canada	Hopital du Sacre-Coeur	Montreal	Quebec
Canada	Princess Margaret Hospital	Ontario
Canada	Hotel-Dieu de Quebec	Quebec
Canada	BC Cancer Agency-Vancouver	Vancouver	British Columbia
France	Centre Regional de lutte contre le cancer Paul Papin	Angers
France	Hôpital Beaujon	Paris
France	Hôpital Saint Antoine	Paris
Germany	Kliniken Essen-Mitte	Essen
Germany	Klinikum Freising	Freising
Germany	Praxis für Innere Medizin, Dr. Oettle Helmut	Friedrichshafen
Germany	LMU Klinikum der Universität	Munich
Germany	Klinikum Oldenburg	Oldenburg
Germany	Universitätsklinikum Würzburg	Würzburg
Italy	I.R.C.C.S. "Giovanni Paolo II" - Istituto Oncologico	Bari
Italy	E. O. Ospedali Galliera, Struttura Complessa Oncologia Medica	Genova
Italy	Nazionale per la Ricerca sul Cancro	Genova
Italy	Fondazione Centro San Raffaele del Monte Tabor	Milano
Italy	Oncologia Medica Falck	Milano
Italy	Istituto Oncologico Veneto	Padova
Italy	IRCCS Policlinico San Matteo	Pavia
Italy	Azienda Ospedaliero universitaria Pisana	Pisa
Italy	Arcispedale Santa Maria Nuova	Reggio Emilia
Italy	Arcispedale Santa Maria Nuova, Unità Operativa di Oncologia Medica	Reggio Emilia
Italy	Istituto Nazionale Tumori "Regina Elena"	Roma
Italy	Istituto Clinico Humanitas	Rozzano
Italy	Ospedale Casa Sollievo della Sofferenza IRCCS	San Giovanni Rotondo, Foggia
Italy	Azienda Ospedaliera Universitaria Integrata di Verona	Verona
Russian Federation	Altai Territorial Oncological Center	Barnaul
Russian Federation	Chelyabinsk Regional Onc Ctr	Chelyabinsk
Russian Federation	Ivanovo Regional Oncology Center	Ivanovo
Russian Federation	Tatarstan Republican Onc Ctr	Kazan	Republic Of Tatarstan
Russian Federation	Regional Oncological Center # 2	Magnitogorsk
Russian Federation	Blokhin Cancer Research Center	Moscow
Russian Federation	Central Clinical Hosp of the President of the Russian Federation	Moscow
Russian Federation	Moscow City Clinical Hosp #57 Chemotherapy Dept	Moscow
Russian Federation	Russian Res Ctr of Radiology under the Fed Agency for Hi-Tech Med Care	Moscow
Russian Federation	Russian Research Ctr of Surgery n.a. B.V. Petrovskiy under the Russian Academy of Med Sciences	Moscow
Russian Federation	Semashko Central Hosp #2	Moscow
Russian Federation	Moscow Municipal Onc Hosp #62	Moscow Region
Russian Federation	Med Radiological Centre of the Russian Academy of Med Sciences	Obninsk	Kaluga Region
Russian Federation	Omsk Regional Onc Ctr	Omsk
Russian Federation	Orenburg Regional Onc Ctr	Orenburg
Russian Federation	Pyatigorsk Affiliate of Stavropol Regional Onc Ctr	Pyatigorsk
Russian Federation	Russian Research Ctr for Radiology and Surgical Technologies	St Petersburg
Russian Federation	St. Petersburg State Med Academy n.a.Mechnikov	St Petersburg
Russian Federation	Clinical Hosp # 122 n.a. L.G. Sokolov	St. Petersburg
Russian Federation	Leningrad Regional Clinical Hosp	St. Petersburg
Russian Federation	St. Petersburg City Onc Ctr	St. Petersburg
Russian Federation	Tula Regional Oncology Center	Tula
Russian Federation	Bashkortostan Republican Onc Ctr	Ufa
Russian Federation	Yaroslavl Regional Onc Ctr	Yaroslavl
Spain	Hospital Clinic i Provincial	Barcelona
Spain	Hospital Vall D´Hebron	Barcelona
Spain	Hospital Universitario Reina Sofia	Córdoba
Spain	Centro Integral Oncológico Clara Campal	Madrid
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Virgen del Rocio	Sevilla
Ukraine	Dnepropetrovsk City Hosp #4	Dnepropetrovsk	UK
Ukraine	Donetsk Regional Antitumor Ctr	Donetsk	UK
Ukraine	Kharkov Regional Onc Ctr	Kharkov
Ukraine	Kherson Regional Onc Ctr	Kherson
Ukraine	Kirovohrad Regional Oncology Center, Department of Chemotherapy	Kirovohrad	UK
Ukraine	Kyiv City Clinical Hospital #10, Center for Hepatic, Bile Duct and Pancreatic Surgery	Kyiv	UK
Ukraine	National Institute of Cancer, Department of Tumors of Abdominal Cavity and Retroperitoneum	Kyiv	UK
Ukraine	Volyn Regional Oncology Center Department of Oncochemotherapy	Lutsk	UK
Ukraine	Lviv Regional Diagnostics and Treatment and Diagnostics Onc Ctr	Lviv	UK
Ukraine	Odessa Regional Onc Ctr	Odessa
Ukraine	Zaporizhia Medical Academy of Postgraduate Education	Zaporizhia
Ukraine	O.F. Herbachevskyi Regional Clinical Hospital, Surgery Center	Zhytomyr	UK
United States	New York Oncology Hematology PC	Albany	New York
United States	Phoebe Putney Cancer Center	Albany	Georgia
United States	Hem Onc Associates-NM	Albuquerque	New Mexico
United States	University of New Mexico	Albuquerque	New Mexico
United States	Cancer Care & Hemaotology Specialists of Chicagoland	Arlington Heights	Illinois
United States	Northeast Georgia Cancer Care, LLC	Athens	Georgia
United States	Atlanta Cancer Care	Atlanta	Georgia
United States	Georgia Cancer Specialists	Atlanta	Georgia
United States	Piedmont Hospital Research Institute	Atlanta	Georgia
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Sidney Kimmel Comphrensive Cancer Center, John Hopkins University	Baltimore	Maryland
United States	Hematology Oncology Clinic	Baton Rouge	Louisiana
United States	Mary Bird Perkins Cancer Center	Baton Rouge	Louisiana
United States	Center for Cancer & Blood Disorders	Bethesda	Maryland
United States	Tower Cancer Research Foundation	Beverly Hills	California
United States	UAB Comprenhensive Cancer Center at University of Alabama	Birmingham	Alabama
United States	Collaborative Research Group	Boynton Beach	Florida
United States	University Cancer Institute, LLC	Boynton Beach	Florida
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Lahey Clinic	Burlington	Massachusetts
United States	Chattanooga Oncology Hematology Associates	Chattanooga	Tennessee
United States	The Center for Cancer and Hematologic Disease	Cherry Hill	New Jersey
United States	Oncology Hematology Care	Cincinnati	Ohio
United States	South Carolina Oncology Associates	Columbia	South Carolina
United States	Mid Ohio Oncology/Hematology Inc	Columbus	Ohio
United States	Medical City Dallas-US Oncology	Dallas	Texas
United States	Texas Oncology, PA	Dallas	Texas
United States	Texas Oncology, PA/ Methodist Charlton Cancer Center	Dallas	Texas
United States	Rocky Mountain Cancer Center	Denver	Colorado
United States	City of Hope	Duarte	California
United States	St. Mary's/ Duluth Clinic	Duluth	Minnesota
United States	NorthShore University HealthSystem	Evanston	Illinois
United States	Fairfax-Northern Virginia Hematology-Oncology, P.C.	Fairfax	Virginia
United States	Virginia Cancer Specialist, PC	Fairfax	Virginia
United States	FL Cancer Specialist	Fort Myers	Florida
United States	Texas Oncology Laboratories	Fort Worth	Texas
United States	The Center for Cancer and Blood Disorders	Fort Worth	Texas
United States	Genesis Cancer Center	Hot Springs	Arkansas
United States	The University of Texas Medical School at Houston	Houston	Texas
United States	Clearview Cancer Institute Oncology Specialities, P.C.	Huntsville	Alabama
United States	Hutchinson Clinic, PA	Hutchinson	Kansas
United States	Indiana University Simon Cancer Center	Indianapolis	Indiana
United States	Kettering Medical Center	Kettering	Ohio
United States	Arena Oncology Associates, PC	Lake Success	New York
United States	Lakeland Regional Cancer Center	Lakeland	Florida
United States	St. Mary Medical Center Hem-Onc Group, PC	Langhorne	Pennsylvania
United States	Cancer Centers of SW OK	Lawton	Oklahoma
United States	Central Maine Medical Center	Lewiston	Maine
United States	Pacific Shores Medical Group	Long Beach	California
United States	UCLA	Los Angeles	California
United States	Owsley Brown Frazier Cancer Center	Louisville	Kentucky
United States	Signal Point Clinical Research Center, LLC	Middletown	Ohio
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota, Masonic Cancer Center	Minneapolis	Minnesota
United States	Virginia Piper Cancer Institute	Minneapolis	Minnesota
United States	Tennessee Oncology	Nashville	Tennessee
United States	Cancer Care & Hematology Specialists of Chicagoland	Niles	Illinois
United States	Ocala Oncology Center	Ocala	Florida
United States	Mercy Physicians of Oklahoma	Oklahoma City	Oklahoma
United States	University of Oklahoma Health Science Center	Oklahoma City	Oklahoma
United States	Florida Hospital Cancer Institute	Orlando	Florida
United States	Illinois Cancer Care	Peoria	Illinois
United States	University of Pittsburg Medical Center	Pittsburgh	Pennsylvania
United States	Texas Oncology- Plano East	Plano	Texas
United States	Mercy Hospital Portland, ME	Portland	Maine
United States	Desert Hematology Oncology Medical Group, Inc.	Rancho Mirage	California
United States	Virginia Cancer Institute	Richmond	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Texas Oncology, PA	Round Rock	Texas
United States	Texas Oncology-Round Rock	Round Rock	Texas
United States	Saint Louis University	Saint Louis	Missouri
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Utah Cancer Specialists	Salt Lake City	Utah
United States	South Texas Oncology and Hematology, P.A	San Antonio	Texas
United States	Maine Center for Cancer Medicine	Scarborough	Maine
United States	Mayo Clinic-Scottsdale	Scottsdale	Arizona
United States	TGEN Clinical Research Services at Scottsdale Healthcare	Scottsdale	Arizona
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Swedish Health Services	Seattle	Washington
United States	Northern Arizona Hematology and Oncology Associates-AOA	Sedona	Arizona
United States	Orchard Research	Skokie	Illinois
United States	Evergreen Hematology & Oncology	Spokane	Washington
United States	St. John's Medical Research Institute	Springfield	Missouri
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Lake County Oncology and Hematology	Tavares	Florida
United States	Arizona Cancer Center, University of Arizona	Tucson	Arizona
United States	Cancer Care Associates- Tulsa	Tulsa	Oklahoma
United States	Texas Oncology, PA	Wichita Falls	Texas
United States	Piedmont Hematology Oncology	Winston-Salem	North Carolina
United States	Cancer Center of Excellence/University of MA Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  France,  Germany,  Italy,  Russian Federation,  Spain,  Ukraine, 

References & Publications (14)

Chiorean EG, Von Hoff DD, Reni M, Arena FP, Infante JR, Bathini VG, Wood TE, Mainwaring PN, Muldoon RT, Clingan PR, Kunzmann V, Ramanathan RK, Tabernero J, Goldstein D, McGovern D, Lu B, Ko A. CA19-9 decrease at 8 weeks as a predictor of overall survival — View Citation

Chiorean EG, Von Hoff DD, Tabernero J, El-Maraghi R, Ma WW, Reni M, Harris M, Whorf R, Liu H, Li JS, Manax V, Romano A, Lu B, Goldstein D. Second-line therapy after nab-paclitaxel plus gemcitabine or after gemcitabine for patients with metastatic pancreatic cancer. Br J Cancer. 2016 Jul 12;115(2):188-94. doi: 10.1038/bjc.2016.185. Epub 2016 Jun 28. Erratum in: Br J Cancer. 2016 Oct 25;115(9):e13. — View Citation

Goldstein D, El-Maraghi RH, Hammel P, Heinemann V, Kunzmann V, Sastre J, Scheithauer W, Siena S, Tabernero J, Teixeira L, Tortora G, Van Laethem JL, Young R, Penenberg DN, Lu B, Romano A, Von Hoff DD. nab-Paclitaxel plus gemcitabine for metastatic pancrea — View Citation

Goldstein D, Von Hoff DD, Moore M, Greeno E, Tortora G, Ramanathan RK, Macarulla T, Liu H, Pilot R, Ferrara S, Lu B. Development of peripheral neuropathy and its association with survival during treatment with nab-paclitaxel plus gemcitabine for patients — View Citation

Kunzmann V, Ramanathan RK, Goldstein D, Liu H, Ferrara S, Lu B, Renschler MF, Von Hoff DD. Tumor Reduction in Primary and Metastatic Pancreatic Cancer Lesions With nab-Paclitaxel and Gemcitabine: An Exploratory Analysis From a Phase 3 Study. Pancreas. 2017 Feb;46(2):203-208. doi: 10.1097/MPA.0000000000000742. — View Citation

Portal A, Pernot S, Tougeron D, Arbaud C, Bidault AT, de la Fouchardière C, Hammel P, Lecomte T, Dréanic J, Coriat R, Bachet JB, Dubreuil O, Marthey L, Dahan L, Tchoundjeu B, Locher C, Lepère C, Bonnetain F, Taieb J. Nab-paclitaxel plus gemcitabine for me — View Citation

Ramanathan RK, Goldstein D, Korn RL, Arena F, Moore M, Siena S, Teixeira L, Tabernero J, Van Laethem JL, Liu H, McGovern D, Lu B, Von Hoff DD. Positron emission tomography response evaluation from a randomized phase III trial of weekly nab-paclitaxel plus — View Citation

Scheithauer W, Ramanathan RK, Moore M, Macarulla T, Goldstein D, Hammel P, Kunzmann V, Liu H, McGovern D, Romano A, Von Hoff DD. Dose modification and efficacy of nab-paclitaxel plus gemcitabine vs. gemcitabine for patients with metastatic pancreatic cancer: phase III MPACT trial. J Gastrointest Oncol. 2016 Jun;7(3):469-78. doi: 10.21037/jgo.2016.01.03. — View Citation

Tabernero J, Chiorean EG, Infante JR, Hingorani SR, Ganju V, Weekes C, Scheithauer W, Ramanathan RK, Goldstein D, Penenberg DN, Romano A, Ferrara S, Von Hoff DD. Prognostic factors of survival in a randomized phase III trial (MPACT) of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic pancreatic cancer. Oncologist. 2015 Feb;20(2):143-50. doi: 10.1634/theoncologist.2014-0394. Epub 2015 Jan 12. — View Citation

Tabernero J, Kunzmann V, Scheithauer W, Reni M, Shiansong Li J, Ferrara S, Djazouli K. nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: a subgroup analysis of the Western European cohort of the MPACT trial. Onco Targets Ther. 2017 Feb 2;10:591-596. doi: 10.2147/OTT.S124097. eCollection 2017. — View Citation

Tehfe M, Dowden S, Kennecke H, El-Maraghi R, Lesperance B, Couture F, Letourneau R, Liu H, Romano A. nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine in Patients with Metastatic Pancreatic Adenocarcinoma: Canadian Subgroup Analysis of the Phase 3 MPACT Trial. Adv Ther. 2016 May;33(5):747-59. doi: 10.1007/s12325-016-0327-4. Epub 2016 Apr 16. Erratum in: Adv Ther. 2016 Nov 24;:. — View Citation

Vogel A, Pelzer U, Salah-Eddin AB, Köster W. First-line nab-paclitaxel and gemcitabine in patients with metastatic pancreatic cancer from routine clinical practice. In Vivo. 2014 Nov-Dec;28(6):1135-40. — View Citation

Vogel A, Römmler-Zehrer J, Li JS, McGovern D, Romano A, Stahl M. Efficacy and safety profile of nab-paclitaxel plus gemcitabine in patients with metastatic pancreatic cancer treated to disease progression: a subanalysis from a phase 3 trial (MPACT). BMC Cancer. 2016 Oct 21;16(1):817. — View Citation

Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Incr — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participants With Treatment Emergent Adverse Events (AE)	A Treatment Emergent Adverse Event (TEAE) is as any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE.	Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 696 days
Other	Number of Participants With Dose Reductions	The number of participants with dose reductions occurring during the treatment period. Dose reductions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.	Maximum time on treatment was 666 days
Other	Number of Participants With Dose Interruptions	The number of participants with dose interruptions experienced by participants that occurred during the treatment period. Dose interruptions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.	Maximum time on treatment was 666 days
Other	Number of Participants With Dose Delays/Doses Not Given	The number of dose delays or doses not given experienced by participants during the treatment period. Dose delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities. Treatment delays of no longer than 21 days allowed participants to recover from acute toxicity, otherwise participants were discontinued from further treatment except in the event of peripheral neuropathy.	Up to 666 days
Primary	Overall Survival (OS)	Overall survival was defined as the time from the date of randomization to the date of death from all causes. Participants who did not die were censored at the last known time the participant was alive. Patient survival was summarized using Kaplan-Meier methods.	From randomization to death; until the data cut off 17 Sept 2012. The maximum time in follow up was 37 months.
Secondary	Progression-free Survival (PFS) by Independent Radiological Review (IRR)	Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the date of the last tumor assessment, on or prior to the clinical cutoff, and the patient was progression free. If a patient began a new anti-cancer treatment prior to documented disease progression (or death), the patient was censored at the date of last assessment when the patient was documented as progression free prior to the intervention. Patients with two or more consecutive missing response assessments prior to a visit with documented progression (or death) were censored at the last date of tumor assessment when the patient was documented to be progression free. PFS was summarized using Kaplan-Meier methods.	Randomization until disease progression or death from any cause; Until the data cut off of 17 Sept 2012. The maximum time in follow up was 37 months.
Secondary	Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR)	Objective tumor response was summarized as the percentage of participants who achieved a confirmed complete (CR) or partial response (PR) based on an independent blinded radiology assessment of response using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Using RECIST Version 1.0, participants were to achieve either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the investigator assessment of best overall response during study treatment.	Assessment every 4 weeks after initial response; Day 1 to data cut off of 17 Sept 2013; maximum time on study 37 months